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| ID | Type | Description | Link |
|---|---|---|---|
| 2026154 | Other Identifier | Eli Lilly |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The goal of this clinical trial is to evaluate the safety and efficacy of Baricitinib in the treatment of frontal fibrosing alopecia (FFA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | All patients will be treated with the active product, Baricitinib. Each patient will take 4mg of Baricitinib daily for 36 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib 4 MG Oral Tablet | Drug | Baricitinib is a Janus kinase (JAK) inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| 30% Change in Lichen Planopilaris Activity (LPPAI) Scores | Percentage of patients achieving 30% change in LPPAI scores. LPPAI is a numeric scale that includes key signs and symptoms of FFA and allows for statistical comparison of disease activity. It captures patient reported symptoms (pruritus, pain, burning), clinical signs (erythema, perifollicular erythema, and scale), and other disease activity features (anagen pull and spreading). The total score distributes 30% weight to symptoms, 30% to signs, 25% to anagen pull, and 15% to spreading. The scale then ranges from 0-10 where 0 is no disease and 10 is worst disease. | From baseline to week 12, 24, and 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Physician Global Assessment (PGA) | Effectiveness of Baricitinib on improvement in Patient Global Assessment.This assessment is a scale from 0 to 4. 0 means clear skin while 4 means severe disease. | From baseline to week 12, 24, and 36 |
| Change in inflammation on histology as seen on scalp biopsy |
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Inclusion Criteria:
Exclusion Criteria:
This condition mostly impacts post-menopausal women.
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| Name | Affiliation | Role |
|---|---|---|
| Boni Elewski, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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Effectiveness of Baricitinib on change of inflammation results on histology exam as seen on scalp biopsy. Degree of lymphocytic infiltrate will be assessed on biopsy and compared to cast thickness on trichoscopy (which correlates with severity of inflammatory changes on pathology). |
| From baseline to week 12,24, and 36 |
| Improvement in trichoscopic grading of peripheral cast by way of Tosti Scale | Effectiveness of Baricitinib on the improvement in trichoscopic grading of peripheral casts (scales). Degree of lymphocytic infiltrate will be assessed on biopsy and compared to cast thickness on trichoscopy by the Tosti Scale. This is a 3 grade measure with Grade 1 being minimum scaling while Grade 3 is maximum scaling. | From baseline to week 12,24, and 36 |
| Improvement in Eyebrow Assessment | Effectiveness of Baricitinib on the improvement of the eyebrow assessment. This is a survey for patients to answer. Answers range from 0 to 3. Answers of 0 mean "I have full eyebrows on each side" while answers of 3 mean " I have no or barely any eyebrow hairs. | From baseline to week 12,24, and 36 |
| Improvement in Visual Analog Scale (VAS) | Effectiveness of Baricitinib on the improvement of the Visual Analog Scale. This is a 10-point visual scale to rate whether the patient's FFA seems to be worse or resolved. | From baseline to week 12,24, and 36 |